RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma

This research study is looking for adults in the UK who have multiple myeloma, a type of blood cancer, that has either returned after treatment or hasn't responded to previous therapies. We are testing a new combination of two medicines, mezigdomide and elranatamab, along with dexamethasone. The main goals are to find the safest and most effective dose of this combination and to see how well it works against multiple myeloma. This is an early-stage study (Phase 1 and 2), which means we are carefully checking for side effects and gathering initial information on how helpful these treatments might be for patients who have limited options.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Celgene

Enrolment target

Start

07 Oct 2025

Estimated completion

03 Jun 2027

Multiple Myeloma

What is this study about?

This study is focusing on a type of blood cancer called multiple myeloma. For some people, multiple myeloma can be difficult to treat, especially if it returns after initial treatments or doesn't respond well to them. This is sometimes called 'relapsed and refractory' multiple myeloma.

Researchers are investigating a new approach using a combination of two medicines: mezigdomide and elranatamab, along with a commonly used steroid called dexamethasone. The hope is that this combination might be more effective at fighting the cancer cells. This study is an important step in understanding these new treatments, as it aims to find the right amount of medication to give (the 'recommended dose') and understand its effects on the body.

The main reasons for doing this study are to make sure the new treatment combination is safe for patients and to get an early idea of how well it works. By carefully monitoring participants, doctors can learn more about how these medicines interact and whether they could become a helpful treatment option for people with multiple myeloma in the future.

Key takeaways

This study is for adults with multiple myeloma that has come back or not responded to other treatments.
It's testing a new combination of two medicines, mezigdomide and elranatamab, with dexamethasone.
The main goals are to find a safe and effective dose, and see how well the treatment works.
It's an early-stage study, meaning doctors are carefully monitoring for safety and initial effectiveness.
Taking part means regular hospital visits for treatments and health checks.

Who may be eligible?

This study is for adults generally aged 18 or older.

To be considered, you must have multiple myeloma that has relapsed (come back) or is refractory (not responding) to previous treatments. Depending on which part of the study you might join, you would need to have had between one and four different types of anti-myeloma treatments before. Importantly, doctors must be able to measure your multiple myeloma to see how it's responding to treatment.

Some things might mean this study isn't right for you. For example, if you've already had a specific treatment called mezigdomide, or certain other types of treatments that work on particular immune cells (T-cells, or those targeting BCMA) – though there might be an exception for a certain type of BCMA treatment if it was more than six months ago. Your study doctor will discuss all the detailed requirements with you to see if you're a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have multiple myeloma that has come back or not responded to previous treatments?
Have you had between 1 and 4 previous treatments for your multiple myeloma, depending on the study part?
Can your multiple myeloma be measured by your doctor?
Have you NOT previously received mezigdomide?
Have you NOT received certain other specific 'T-cell engaging' treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive regular doses of the study medicines: mezigdomide, elranatamab, and dexamethasone. These will be given according to a specific schedule set by the study doctors. You will have regular visits to the hospital or clinic for these treatments and for check-ups.

During these visits, the study team will carry out various tests, including blood samples and other assessments, to monitor your health, check for any side effects, and see how well the treatment is working against your multiple myeloma. Your doctors will also monitor your overall health and well-being. The full duration of your participation in the study, including follow-up after the main treatment period, will be clearly explained by the study team.

Potential risks and benefits

Like all medical treatments, there are potential benefits and risks to consider. A potential benefit of taking part in this study could be access to a new treatment combination for your multiple myeloma that might help where previous treatments haven't. However, new treatments can also have side effects, and doctors are carefully studying these in this trial. There's no guarantee that the treatment will work for everyone, or that it won't cause side effects. Your safety is a top priority, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
Yale New Haven Hospital-Smilow Cancer Center
Verified postcode
New Haven, United States· Recruiting
Hackensack University Medical Center
Verified postcode
Hackensack, United States· Recruiting
University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
Arthur J E Child Comprehensive Cancer Centre
Verified postcode
Calgary, Canada· Recruiting
Local Institution - 0026
Verified postcode
Vancouver, Canada· Not yet recruiting
QEII Health Sciences Centre - Victoria General Site
Verified postcode
Halifax, Canada· Recruiting
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting
Local Institution - 0030
Verified postcode
Suzhou, China· Not yet recruiting
Local Institution - 0031
Verified postcode
Shanghai, China· Not yet recruiting
Universitaetsklinikum Carl Gustav Carus Dresden
Verified postcode
Dresden, Germany· Recruiting
Universitaetsklinikum Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that starts in plasma cells, which are white blood cells found in your bone marrow.

What does 'relapsed and refractory' mean?

It means your multiple myeloma has either come back after previous treatments or hasn't responded to earlier treatments.

Are the medicines in this study new?

Yes, mezigdomide and elranatamab are being studied in combination to see if they can effectively treat multiple myeloma. Dexamethasone is a commonly used medication.

What 'phase' is this study?

This is a 'Phase 1 and 2' study. This means it's an early-stage study focusing on finding the right dose and checking for safety, while also getting a first look at how well the treatment works.

Will I receive a placebo?

No, participants in this study will receive the active study medicines, mezigdomide, elranatamab, and dexamethasone.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.